Glenosphere Orientation Guide - Instrument used to implant Delta XTEND Reverse Shoulder System

Health professionals and consumers are advised that Johnson & Johnson Medical, after consultation with the TGA, is issuing a hazard alert to implanting surgeons regarding one lot of its Glenosphere Orientation Guide (lot number 5120443).

The Glenosphere Orientation Guide is an instrument used by surgeons to align components of the Delta XTEND Reverse Shoulder System, a total shoulder replacement system. Specifically, the instrument is used for eccentric glenosphere orientation of the implant.

It has been identified that, in the affected lot, an arrow etched onto the instrument is located on the wrong side of the device. This etching error could lead to incorrect placement of the glenosphere and consequently a number of potential complications.

Only one Glenosphere Orientation Guide from the affected lot was supplied in Australia and it was removed from circulation in March 2013. However, the instrument is a reusable device and may have been used in a number of implantations of the Delta XTEND Reverse Shoulder System prior to being removed from circulation.

Information for consumers

You should contact your general practitioner or orthopaedic surgeon if you have had a shoulder replacement and you experience pain or limited range of motion in your shoulder.

Information for all health professionals

Patients with any shoulder replacement should be followed up by the implanting orthopaedic surgeon if possible, particularly if the patient complains of pain or limited range of motion associated with their shoulder implant and surgery.

Information for orthopaedic surgeons

Patients who have received a Delta XTEND Reverse Shoulder System prior to March 2013 should be followed-up according to their routine protocol and assessed for complications that could be associated with this issue at that time.

Incorrect placement of the glenosphere during implantation of the Delta XTEND Reverse Shoulder System can potentially lead to the following complications:

• pain
• poor joint mechanics, with polyethylene insert notching occurring between the insert and the scapula at an earlier adduction angle
• osteolysis due to polyethylene wear
• loosening of the glenosphere/metaglene due to either osteolysis or inferior screw breakage
• bone fracture.

Prophylactic revision is not recommended. However, surgeons should consider revision surgery if symptoms are evident and incorrect placement is suspected.

Additional information

Two complaints regarding the incorrect arrow etching on the Glenosphere Orientation Guide instrument have been received globally. However, neither of those reports indicated that the issue had resulted in incorrect placement of the glenosphere.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

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